đź“Š Evidence-Based Reference
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Togo Medikit
Summary: The Super Sheath Introducer Sheath by Togo Medikit is a Class 2 medical device cleared by the FDA for use in embolization-coil procedures. Key evidence highlights its application in vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K241230 ↗
Decision Date
September 17, 2024
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Super Sheath Introducer Sheath was cleared through the FDA 510(k) pathway on September 17, 2024. Manufactured by Togo Medikit, it is classified as a Class 2 device.
What It Is
The Super Sheath Introducer Sheath is a medical device designed to facilitate the introduction of catheters and other instruments into the vascular system. It is primarily used in embolization-coil procedures to provide a conduit for device delivery.
Clinical Applications
Commonly used in interventional radiology and cardiology, the Super Sheath Introducer Sheath is employed in procedures requiring vascular access, such as transcatheter aortic valve implantation and other endovascular interventions.
Evidence Summary
The literature includes five studies ranging from 2014 to 2025, covering various clinical scenarios involving the use of introducer sheaths. Study types include case series and experimental models.
Reported Outcomes
Published studies report the use of the Super Sheath Introducer Sheath in complex vascular procedures, highlighting its role in facilitating successful device delivery. Outcomes include effective management of vascular complications and procedural success in challenging cases.
Safety Profile
Reported complications include vascular injury and occlusion, as noted in a case of transcatheter aortic valve implantation. Other studies highlight the need for careful handling to avoid vessel damage.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term safety and efficacy across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Super Sheath Introducer Sheath?
The device is indicated for use in embolization-coil procedures and other vascular interventions requiring introducer sheaths.
What outcomes have been reported in clinical studies?
Studies report successful device delivery and management of vascular complications in complex procedures.
What complications have been reported?
Safety data indicate potential complications such as vascular injury and occlusion during use.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.